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Technical Writer - Pharmaceutical

Technical Writer - Pharmaceutical

Hubot | Tri Pac, Inc. CDMOMumbai, India
8 days ago
Job description

Technical Writer / Document Control Specialist (Pharma) – India → U.S. Support

Mumbai, India | Full-Time | On-site | U.S. Overlap

Turn complex manufacturing and quality work into clear, compliant, releasable records. Hubot, Inc. (CDMO) is hiring a pharma Technical Writer / Document Control Specialist to support our U.S. operations—authoring and QA-grade reviewing BMR / BPR, Specifications, SOP / WI, APR / PQR, and Product Release packages inside a validated eQMS.

Why Join Hubot?

25–30% YoY growth with momentum through 2030

4.8 Glassdoor | 4.7 Indeed | 95% recommend | Wellbeing 79

Impact that counts : Your documents enable batch release and audit readiness in the U.S.

Global collaboration : Daily partnership with U.S. QA / Manufacturing / Validation / Regulatory

Career path : Senior Writer → Documentation Lead → Quality Systems / Regulatory Docs

What You'll Do

  • Draft, edit, and review BMR / BPR and packaging records to GDP standards
  • Create / maintain raw / pack / FG specifications; manage redlines and version control
  • Compile release packages; verify vs. specs, CoA / CoC, deviations / CAPA; sign off as authorized
  • Build APR / PQR trend reports (OOS / OOT, deviations, complaints, stability, yields)
  • Author / revise SOPs / WIs / forms / process flows; route via eQMS / DMS with full change control
  • Support audit / inspection readiness and rapid document retrieval

Who You Are (Pharma-first)

  • 5+ years in GMP technical writing / document control within pharma / biopharma / OTC / device / CDMO
  • Fluent in 21 CFR 210 / 211, cGMP / GDP, ALCOA+, change control, deviations / CAPA, OOS / OOT
  • Comfortable in eQMS / DMS (DOT Compliance / Track Wise), ERP / LIMS context
  • Exceptional written English; meticulous editor; thrives with U.S. time-zone overlap
  • Success Metrics

  • ≥98% RFT docs (zero critical GDP errors)
  • ≥95% on-time routing / approval vs. SLA
  • 20–30% faster cycle times via standardization
  • Ready to write the records that release the products? Apply or message us directly.

    For a more detailed brief, visit #DocumentControl #GMP #GDP #ALCOA #QMS #CDMO #BatchRecords #PharmaJobs #MumbaiJobs

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    Technical Writer • Mumbai, India

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